Gait modulation system and method

• US 8,972,017 B2
• Filed: 06/25/2012
• Issued: 03/03/2015
• Est. Priority Date: 11/16/2005
• Status: Active Grant

• Current Assignee: Bioness Neuromodulation Ltd.
• Original Assignee: Bioness Neuromodulation Ltd.
• Inventors: Dar, Amit, Shalev, Yossef, Bar-Or, Jonathan, Nathan, Roger
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US13/532,603
• Publication Number:
  US 20120330395A1
• Time in Patent Office: 981 Days
• Field of Search: 607/48, 607/144
• US Class Current: 607/48
• CPC Class Codes: A61B 5/1038 Measuring plantar pressure during gait
• CPC Class Codes: A61B 5/6807 Footwear
• CPC Class Codes: A61B 5/6828 Leg
• CPC Class Codes: A61F 5/01 Orthopaedic devices, e.g. splints, casts or braces
• CPC Class Codes: A61H 3/00 Appliances for aiding patients or disabled persons to walk about apparatus for helping babies to walk A47D13/04 ; applying electrical currents by contact electrodes for stimulating motor muscles, e.g. walking assistance A61N1/36003
• CPC Class Codes: A61N 1/0452 Specially adapted for transcutaneous muscle stimulation [TMS]
• CPC Class Codes: A61N 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• CPC Class Codes: G01L 1/20 by measuring variations in ohmic resistance of solid materials or of electrically-conductive fluids of piezo-resistive materials G01L1/18; by making use of electrokinetic cells, i.e. liquid-containing cells wherein an electrical potential is produced or varied upon the application of stress
• CPC Class Codes: H01H 3/14 adapted for operation by a part of the human body other than the hand, e.g. by foot
• CPC Class Codes: H03K 17/9625 using a force resistance transducer

Abstract

Methods related to an electrical stimulation orthosis are disclosed herein. In some embodiments, a method includes disposing a connector of a stimulation electrode assembly through an opening defined by a detachable layer. The connector of the stimulation electrode assembly is reversibly coupled to a connector disposed on an inner face of a frame. The detachable layer is coupled to the inner face of the frame. The method further includes disposing the frame about a limb segment of a body such that the detachable layer is in contact with a portion of the limb segment, and an electrical stimulation electrode of the stimulation electrode assembly is in contact with at least one stimulation point on a surface of the body associated with at least one of a nerve or a muscle.

Claims

1. A method, comprising:

placing a portion of a limb through a frame opening defined by a first member of a frame assembly and a second member of the frame assembly, an end portion of the first member spaced apart from an end portion of the second member to define the frame opening, the frame assembly including a surface electrode coupled to an inner surface of the frame assembly such that the surface electrode is disposed at a predetermined position overlying a peroneal nerve when the frame assembly is disposed about the portion of the limb, the frame assembly including an electronic stimulator configured to produce a current to the surface electrode;

coupling a fastening strap across the opening; and

actuating the electronic stimulator to produce dorsiflexion of a foot.

2. The method of claim 1, wherein the coupling the fastening strap includes disposing a loop member of the fastening strap about a protrusion on the frame assembly.

3. The method of claim 1, wherein the coupling the fastening strap includes disposing at least a portion of the fastening strap about the electronic stimulator coupled to the frame assembly.

4. The method of claim 1, further comprising:

electrically coupling the surface electrode to the electronic stimulator via a connector assembly, at least a portion of the connector assembly disposed within a connector opening defined by the frame assembly.

5. The method of claim 1, wherein:

the first member of the frame assembly and the second member of the frame assembly are constructed from a semi-rigid material; and

the placing includes placing the first member and the second member about the portion of the limb such that the first member and the second member exert a force about the portion of the limb.

6. The method of claim 1, wherein the placing includes positioning the frame assembly about the portion of the limb using a single hand.

7. A method, comprising:

placing a portion of a limb within an orthosis opening defined by a first layer of an orthosis assembly, a first end portion of the first layer spaced apart from a second end portion of the first layer to define the orthosis opening, the first layer including a mounting portion coupled to an electronic stimulator, the orthosis assembly including a second layer in contact with a surface electrode electrically coupled to the electronic stimulator via a connector assembly disposed at least partially within a connector opening defined by at least one of the first layer or the second layer;

positioning the orthosis assembly about the portion of the limb such that the surface electrode is disposed at a position overlying a peroneal nerve;

coupling a fastening strap across the opening; and

actuating the electronic stimulator to transmit electrical stimulation to the portion of the limb via the surface electrode to produce dorsiflexion of a foot.

8. The method of claim 7, wherein:

the first layer includes a locator configured to identify at least one of a longitudinal position or a rotational position of the first layer relative to the portion of a limb; and

the positioning includes moving the orthosis assembly based on a location of the locator.

9. The method of claim 7, wherein a first end of the fastening strap is coupled to the mounting portion of the first layer.

10. The method of claim 7, wherein:

the first layer of the orthosis assembly is constructed from a semi-rigid material; and

the placing includes placing the first layer about the portion of the limb such that the first layer exerts a force about the portion of the limb.

11. The method of claim 7, wherein the coupling the fastening strap includes disposing a loop member of the fastening strap about a protrusion on the orthosis assembly.

12. The method of claim 7, wherein the second layer includes an electrode base configured to couple the surface electrode to the second layer.

13. A method, comprising:

placing a portion of a limb within an orthosis opening defined by a first layer of an orthosis assembly, a first end portion of the first layer spaced apart from a second end portion of the first layer to define the orthosis opening, the first layer including an electronic stimulator mounted thereto, the orthosis assembly including a second layer in contact with a surface electrode electrically coupled to the electronic stimulator via a connector assembly disposed at least partially within a connector opening defined by at least one of the first layer or the second layer;

coupling a fastening strap across the opening to maintain the surface electrode in a predetermined position relative to the portion of the limb; and

actuating the electronic stimulator to transmit electrical stimulation to the portion of the limb via the surface electrode to produce dorsiflexion of a foot.

14. The method of claim 13, wherein the predetermined position overlies a peroneal nerve.

15. The method of claim 13, wherein:

the first layer includes a locator configured to identify at least one of a longitudinal position or a rotational position of the first layer relative to the portion of a limb; and

the coupling includes moving the orthosis assembly based on a location of the locator.

16. The method of claim 13, wherein:

the first layer includes a mounting portion configured to at least partially receive the electronic stimulator; and

a first end of the fastening strap is coupled to the mounting portion.

17. The method of claim 13, wherein:

the first layer of the orthosis assembly is constructed from a semi-rigid material; and

the placing includes placing the first layer about the portion of the limb such that the first layer exerts a force about the portion of the limb.